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A Novel Approach to Plantar Fasciitis in the Aging Population The NAPA trial

Award Number: R01AG071646
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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A Novel Approach to Plantar Fasciitis in the Aging Population The NAPA trial - Contact PD/PI: DAVIS, IRENE S Plantar fasciitis, a repetitive strain injury, is one of the most common causes of foot pain. Ten percent of aging adults experience plantar fasciitis with 50% of the cases being disabling. Foot pain can lead to other problems such as reduced mobility, depression and prescription medication use, leading to a reduced quality of life. Relationships have been established between foot pain and weakness, reduced static and dynamic balance, and reduced walking speed in aging adults. The standard of care for plantar fasciitis is to brace the foot with foot orthoses and supportive shoes. However, chronic support of the arch has been shown to lead to intrinsic foot muscle atrophy. As plantar fasciitis is associated with this atrophy, treating it with chronic arch support only increases the risk for recurrence. In fact, there is a 50% recurrence rate and a 45.6% risk of having plantar fasciitis 10 years after the onset of symptoms in older adults. Minimal shoes are designed to allow the foot to function naturally, as if barefoot. They have already been successfully implemented in older adults for the treatment of knee osteoarthritis. Minimal shoes are highly flexible and lack the support of conventional footwear. This places greater demand on the foot muscles which promotes strengthening. Stronger foot intrinsic foot muscles have been shown to reduce the strain on the plantar fascia with each step, thereby reducing the risk of developing plantar fasciitis. Long-term Goal: To improve treatment interventions for plantar fasciitis in aging adults. Specific Aims: 1. Compare pain and physical function between the minimal footwear (MF) and the foot orthotic (FO) groups at the 3 and 6 month follow-up, 2. Compare changes in intrinsic foot muscle size and strength between MF and FO groups at the 3 and 6 month follow-up, and 3. Compare the incidence of recurrence of plantar fascial pain between the MF and FO groups at the 12 month follow-up Methods: 120 participants with plantar fasciitis (>6 mos.) will be recruited from 2 sites. They will be randomized into a minimal footwear (MF) and foot orthotic (FO) group. Baseline measures of foot muscle size and strength, static and dynamic balance, 6 min. walk test and two functional outcome questionnaires will be obtained. The MF group will receive 2 pair of minimal shoes, and the FO group will receive 2 pair of supportive shoes and prefabricated foot orthoses. The MF group will be given a 4-week program of foot strengthening and flexibility exercises, while the FO group will only receive the flexibility exercises. Both groups will be given an 8-week footwear transition program based upon their individual baseline step counts. They will return to the laboratory to repeat the baseline measures at 3 and 6 mos. Plantar fascial pain and daily step counts will be monitored over the course of the year. Comparisons in outcome measures as well as plantar fasciitis recurrence will be compared between the groups. Project Summary/Abstract Page 6


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $99,720 )
2025	2025	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	000	3	3/12/2025	SUPPLEMENT FOR EXPANSION	$99,720
														Subtotal = $99,720

Issue Date FY: 2024 ( Subtotal = $497,235 )
2024	2024	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	000	3	6/13/2024	NON-COMPETING CONTINUATION	$497,235
														Subtotal = $497,235

Issue Date FY: 2023 ( Subtotal = $526,753 )
2023	2023	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	002	2	7/11/2023	NON-COMPETING CONTINUATION	$526,753
2023	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	001	1	5/19/2023	NEW	$0
2023	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	000	1	1/20/2023	NEW	$0
														Subtotal = $526,753

Issue Date FY: 2022 ( Subtotal = $773,090 )
2022	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	000	1	8/23/2022	NEW	$773,090
														Subtotal = $773,090

Grand Total All Awards = $1,896,798

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A Novel Approach to Plantar Fasciitis in the Aging Population The NAPA trial

Award Number: R01AG071646

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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